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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Wipro GE Healthcare Private Ltd.: Giraffe and Panda iRes Warmers Recalled for Incomplete Electrical Safety Testing

Agency Publication Date: September 20, 2024
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Summary

Wipro GE Healthcare has recalled approximately 138 Giraffe and Panda iRes Warmers due to incomplete electrical safety testing during the manufacturing process. These radiant warmers are used in hospitals to provide infrared heat to newborn babies who cannot regulate their own body temperature. While the devices include multiple safety protections, the lack of complete testing means some units may have electrical leakage that exceeds safe international standards. Consumers should identify if their unit is affected and contact GE HealthCare for further instructions.

Risk

The incomplete testing creates a risk that electrical leakage current could exceed safety limits, potentially leading to an electrical shock hazard for patients or healthcare providers. No injuries or specific incidents have been reported in the provided data.

What You Should Do

  1. Identify if your device is affected by checking the Model/Catalog Number and Serial Number on the product label. The recalled units include the GE Giraffe Warmer (Model M1118179-01090979, Serial GBW24230381SA) and various GE Panda iRES Warmer models.
  2. Check your Panda iRES Warmer specifically for the following Model Numbers: M1112198-01045518, M1112198-01045579, M1112198-01047148, M1112198-01047271, M1112198-01048731, M1112198-01048740, M1112198-01052386, M1112198-01054697, M1112198-01068942, M1112198-01084972, M1112198-01090848, M1112198-01093457, M1112198-01117766, M1112198-01139893, M1112198-01156745, M1112198-01167230, M1112198-01177090, M1112198-01183599, M1112198-01185372, M1112198-01193801, M1112198-01200764, M1112198-01245548, M1112198-01253742, and M1112198-01274059.
  3. Review the serial numbers for Panda iRES Warmers to confirm your unit is involved; affected serials include sequences such as PBW23420278SA, PBW24241071SA, PBW23492144SA, and others listed in the manufacturer's notification.
  4. Contact your healthcare provider or GE HealthCare directly for further instructions regarding the safety of these devices and to arrange for any necessary testing or corrective actions.
  5. For additional questions or to report problems, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated contact via letter

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: GE Giraffe Warmer
Model / REF:
M1118179-01090979
Lot Numbers:
Serial Number GBW24230381SA
Product: GE Panda iRES Warmer
Model / REF:
M1112198-01045518
M1112198-01045579
M1112198-01047148
M1112198-01047271
M1112198-01048731
M1112198-01048740
M1112198-01052386
M1112198-01054697
M1112198-01068942
M1112198-01084972
M1112198-01090848
M1112198-01093457
M1112198-01117766
M1112198-01139893
M1112198-01156745
M1112198-01167230
M1112198-01177090
M1112198-01183599
M1112198-01185372
M1112198-01193801
M1112198-01200764
M1112198-01245548
M1112198-01253742
M1112198-01274059
UPC Codes:
00840682152709
00840682152716
Lot Numbers (137):
PBW23420278SA
PBW23390175SA
PBW24241071SA
PBW24241072SA
PBW24241075SA
PBW23340090SA
PBW24241078SA
PBW24241079SA
PBW24241063SA
PBW24241076SA
PBW24241068SA
PBW24241070SA
PBW24241065SA
PBW24241064SA
PBW24241066SA
PBW24241067SA
PBW24241069SA
PBW23492144SA
PBW23482075SA
PBW23492149SA
PBW24062087SA
PBW24062078SA
PBW24062081SA
PBW23492145SA
PBW24152231SA
PBW24152225SA
PBW24152229SA
PBW23482085SA
PBW24202294SA
PBW24202292SA
PBW24202293SA
PBW24212323SA
PBW24212324SA
PBW24152226SA
PBW24152227SA
PBW24052060SA
PBW23492142SA
PBW24241087SA
PBW24241086SA
PBW24241085SA
PBW23320042SA
PBW23320041SA
PBW24241084SA
PBW23320035SA
PBW23482093SA
PBW23482100SA
PBW24202309SA
PBW24202313SA
PBW24202310SA
PBW24202315SA

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95216
Status: Active
Manufacturer: Wipro GE Healthcare Private Ltd.
Sold By: GE HealthCare; authorized medical distributors
Manufactured In: India
Units Affected: 2 products (1; 137 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.